GameSquad for Adults With Down Syndrome: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for GameSquad for Adults With Down Syndrome (NCT05473247), a na na study. The primary outcome is Minutes of Gameplay Per Week.

2. Clinical Question

This is a feasibility-focused question rather than a comparison of treatment effects. The study description says investigators are assessing acceptability, appropriateness, and feasibility using validated scales alongside qualitative data. It also identifies gameplay minutes, attendance at virtual sessions, interviews, participant retention, and intervention safety as areas of interest. These aims concern whether the adapted program can be delivered and how participants engage with it; they do not by themselves establish a causal effect on physical activity or health.

The intervention description includes Ring-Fit Adventure and virtual health-related sessions, but the record does not provide a complete account of every study activity. It describes Phase 1 gameplay as 60 minutes per week for 4 weeks, alongside a weekly, 90 minute health education session. The brief summary instead refers to attendance at 30 min. virtual health coaching sessions, and the Phase 2 arm description is cut off. The registry record does not reconcile these descriptions.

3. Trial Design

The study is listed as a completed, single-group behavioral intervention, with an enrollment of 20. Allocation is recorded as NA, and masking is listed as none. Those design features mean the record does not describe random assignment or a blinded assessment. There is no separate control arm against which changes can be compared. The trial is titled as a pilot feasibility study, and its stated focus is acceptability, appropriateness, and feasibility of an adapted GameSquad intervention for young adults with Down syndrome.

The record gives a start date of 2023-01-15 and a primary completion date of 2023-06-30. It lists the study status as completed. The intervention is named Ring-Fit Adventure Group. In Phase 1, participants were asked to play Ring-Fit Adventure for 60 minutes per week for 4 weeks and to attend a weekly, 90 minute health education session with a health educator on zoom. The Phase 2 description stops after an incomplete gameplay instruction, so its full schedule is not reported in the registry record.

The brief summary describes a weekly 30 min. virtual health coaching session, which differs from the 90 minute health education session in the arm description. Without a fuller record, these descriptions cannot be combined into a single definitive schedule. No protocol details beyond the descriptions in the registry record are reported. The record lists 10 outcome measures, including the primary gameplay measure and secondary measures such as the 6-minute Walk Test, leg strength, hand grip strength, Timed Up and Go, balance, adverse events, and qualitative interview data. It lists no analyses. Thus, completion status and listed outcomes should not be mistaken for published outcome findings: the registry record does not report estimates for the primary or secondary outcomes.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Minutes of Gameplay Per Week, measured over 12-weeks.

The primary endpoint is minutes of Ring-Fit Adventure gameplay per week. The registry record says gameplay minutes will be collected from a self-reported sign-in sheet, with a 12-weeks timeframe. The endpoint therefore describes participants’ reported engagement with the game over time, rather than a direct measure of fitness or a comparison between intervention and control groups. It is expressed in minutes/week, and the intended summary is a mean with standard deviation.

For a feasibility study, a measure of actual participation can help characterize whether participants engage with a program as intended. Gameplay time also gives a concrete measure of exposure to the exergaming activity. However, a self-reported sign-in sheet depends on participants’ recording of their activity. The registry record does not report whether entries were checked against device logs, how incomplete weeks were handled, or how the weekly values were combined over the timeframe.

The mean describes an average level of reported gameplay, while the standard deviation describes how spread out individual values are around that average. Neither can be interpreted without the corresponding observed values, and neither establishes that the intervention caused any change. No primary endpoint result, estimate of variability, or analysis population is reported in the registry record. The measure’s stated purpose and collection method are available, but the observed gameplay pattern is not.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study’s primary outcome is continuous: it is a quantity measured in minutes per week. The registry record specifies a mean and standard deviation as the intended summary. A mean condenses individual measurements into an average, while the standard deviation describes the spread of those measurements. Together, they can convey both typical reported gameplay and variation between participants, but they do not reveal the full distribution. A few unusually high or low values can affect the mean, and the same mean and standard deviation can accompany different patterns in the underlying observations.

These summaries are useful only when the observed values and the population used to calculate them are available. The registry record does not report the primary mean or standard deviation, nor does it report a confidence interval. A confidence interval is a general statistical way to express uncertainty around an estimate: it reflects how much the estimate might vary under the assumptions of the analysis. Its width depends on the data and analysis, so no interval can be reconstructed from the endpoint definition alone.

Gameplay time is self-reported on a sign-in sheet. In general, self-reported measures can be affected by incomplete recording or recall, and such issues can influence both the average and the apparent variability. The registry record does not say whether gameplay was independently verified, how missing sign-in entries were treated, or whether the analysis used weekly values, an average across the timeframe, or another summary. Those details are not reported in the registry record and should not be assumed.

What does the single-group design allow?

A single-group study can describe what was observed among participants who took part. Without a separate comparison group, it cannot directly distinguish an intervention-related change from other influences that occur over time. Random allocation is listed as NA, and the study model is single-group. Therefore, a two-arm treatment comparison is not part of the design described in the registry record. The lack of masking is also recorded, but the registry does not provide further information about who knew which study details or how outcome recording was managed.

The record describes a pilot feasibility purpose. In general, feasibility studies can help assess whether an intervention and its measurements can be implemented and can identify practical questions for later research. They are not automatically designed or powered to establish clinical effectiveness. The registry record does not report a sample-size justification, a statistical analysis plan, or a prespecified hypothesis-testing strategy. Those features cannot be inferred from the enrollment figure or from the study’s completion status.

How should uncertainty and variability be considered?

Minutes of gameplay may vary between participants, and the mean alone would not show whether most participants played similar amounts or whether reports were widely dispersed. The standard deviation is the listed measure of dispersion, but no value is reported. General statistical practice also considers whether a continuous outcome has a distribution that makes a mean-based summary informative. Over-dispersion, in general, means that the observed spread is greater than a chosen statistical model would expect. It can make standard errors or confidence intervals from that model unreliable if the model does not account for the extra variability. The registry record does not provide a distributional assessment or enough data to determine whether over-dispersion is relevant in this study.

The record also lists a sample-size planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are planning assumptions, not evidence that this single-group study used a two-arm design. The record does not report an observed primary effect that could anchor such an illustration. Planning sample sizes are not observed power, and they do not demonstrate that an outcome was detected or not detected. Any planning illustration should be kept separate from the study’s actual enrollment and reported findings.

What analyses are documented?

The registry record lists 10 outcome measures but no analyses. It does not describe a primary endpoint model, adjustments for covariates, handling of repeated weekly measurements, confidence intervals, or hypothesis tests. Nor does it report qualitative coding procedures for interview data. These omissions do not establish that no analysis was conducted outside the registry; they mean that the analysis details and results are not reported in the registry record. Statistical interpretation must therefore remain limited to the design, outcome definitions, and safety counts that are explicitly recorded.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Ring-Fit Adventure Group")
n   <- c(19)
m   <- c(100.32)
sp  <- c(8.65)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Ring-Fit Adventure Group  19  100.320  8.650  96.151  104.489

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 10 outcome measures, spanning gameplay, physical-function measures, adverse events, and qualitative interview data. When a study examines multiple outcomes, there are general statistical considerations about multiplicity: the more questions assessed, the more opportunities there may be for apparently notable findings by chance. Researchers may address this through a prespecified hierarchy, adjusted inference, or a clearly exploratory interpretation. The registry record does not report a multiplicity strategy, outcome hierarchy beyond identifying gameplay minutes as primary, or adjustment method.

The record lists no analyses and does not report outcome estimates or tests. It is therefore not possible to determine whether multiplicity adjustments were applied, whether measures were analyzed as exploratory, or how results were selected for reporting. The absence of such details in the registry record should not be taken as evidence that a particular method was or was not used elsewhere.

Missing-data handling is also not reported in the registry record. The primary measure relies on self-reported sign-in sheets, but there is no description of missing entries, incomplete follow-up, participant withdrawal, or the approach used to include available observations. The record does not state whether any imputation or other missing-data method was used.

The analysis population is not reported in the registry record. Enrollment is listed as 20, but that does not establish how many participants contributed data to any particular endpoint. The record does not say whether analyses used all enrolled participants, participants who began the intervention, those with complete outcome data, or another defined group. No denominator for the primary endpoint is reported. Consequently, readers cannot assess how missing measurements or analysis-population choices might affect an outcome estimate.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The serious adverse event entry records zero events among 20 at risk in the Ring-Fit Adventure Group. The entry for other adverse events also records zero events among 20 at risk in that group. These are the safety counts in the registry record; they describe what was entered for the listed categories and group.

A recorded zero is not the same as proof that an intervention is free of risk. Interpretation depends on how events were defined, collected, monitored, and reported, and those details are not reported in the registry record. The entry does not provide descriptions of specific events, follow-up duration for safety, or information about whether participants experienced symptoms that did not meet the reporting categories. The absence of listed serious-event terms likewise does not provide additional evidence beyond the recorded count.

The safety figures should also be kept separate from the unreported primary gameplay result and the other unreported outcome findings. They are counts, not a comparative estimate: the study has no separate control group. The registry entry therefore does not allow a comparison of adverse-event frequency between intervention and control conditions. The appropriate reading is limited to the recorded counts for the Ring-Fit Adventure Group and the reporting details available in the registry.

13. What the Result Does, and Does Not, Mean

The record establishes that a completed, single-group pilot feasibility study was registered for an adapted GameSquad exergaming intervention in young adults with Down syndrome. It identifies Ring-Fit Adventure gameplay minutes per week as the primary outcome and gives a self-reported sign-in sheet as the measurement method. It also describes feasibility-related aims, virtual sessions, interviews, retention, safety, and secondary physical-function measures.

What the record does not establish is how much participants played, how variable their gameplay was, whether they attended the planned sessions, or how they rated the program. No primary outcome estimate or result for the listed secondary measures is reported in the registry record. Without these findings, it is not possible to judge the degree of engagement, the feasibility outcomes, or the precision of an estimate.

The single-group design has no concurrent control comparison. Thus, the registry record does not support a causal comparison between receiving the intervention and not receiving it. The title and intervention description also do not establish that the program improved fitness or changed physical activity. Such conclusions would require reported outcome data and an analysis suited to the question; the registry record does not provide them.

The safety entry records zero serious adverse events and zero other adverse events in the intervention group, with 20 at risk in each entry. This is useful as a description of recorded events, but it is not a guarantee of safety or a comparison with another group. The record does not provide the monitoring procedures needed to assess how completely events were captured.

Overall, the registry record supports a description of the study’s intended feasibility focus, intervention, design, and recorded safety counts. It does not report enough outcome information to determine what participants experienced on the primary measure or what the study found about its other aims. A pilot feasibility designation is not itself evidence of success or failure.

14. Why This Trial Matters Statistically

This trial is statistically important to read in the context of its stated pilot feasibility purpose. The study focuses on whether an adapted exergaming program can be assessed among young adults with Down syndrome, with gameplay time, session attendance, participant retention, interviews, and safety identified as relevant areas. These are different kinds of evidence: a continuous gameplay measure, attendance and retention information, qualitative accounts, and event counts do not answer the same question or use the same interpretation.

The primary endpoint is concrete and interpretable in units of minutes per week, but its value is not reported in the registry record. This distinction matters: a registered measurement plan is not an outcome finding. Without an estimate and its variability, readers cannot assess the amount of gameplay or the precision with which it was measured. The absence of a separate comparison group also means that the design is descriptive rather than a randomized estimate of an intervention effect.

The record highlights an additional issue for statistical interpretation: the planning assumptions describe equal allocation between two arms, while the registered study is single-group. Planning illustrations can help frame future research, but they do not describe the design actually used and do not constitute observed power. In this case, the record also does not report an observed primary effect to inform such illustrations.

Finally, the intervention schedule is not fully clear in the registry record. The Phase 1 description and brief summary give different session durations, and the Phase 2 description is incomplete. Clear intervention reporting is important for interpreting exposure, replicating procedures, and connecting gameplay measurements to the program participants were asked to follow. These reporting limits reinforce why the available record supports a careful account of design and intended measurement, but not conclusions about outcome patterns.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation for interpretation is that the registry record does not report results for the primary endpoint. It describes minutes of gameplay per week and the self-reported collection method, but gives no mean, standard deviation, confidence interval, or analysis. Results for the listed secondary outcomes, including physical-function measures and qualitative interview data, are also not reported.

The single-group design has no separate control arm, and allocation is recorded as NA. The record therefore does not describe a randomized comparison or a basis for estimating a difference against a concurrent control group. The lack of masking is recorded, but further details about outcome assessment are not reported in the registry record.

Intervention details are incomplete. The brief summary refers to weekly 30 min. virtual health coaching sessions, whereas the Phase 1 arm description gives a weekly, 90 minute health education session. The Phase 2 description is truncated. The registry record does not explain these discrepancies or provide a complete schedule. This makes the intervention exposure difficult to characterize from the record alone.

Important analysis and data-quality details are not reported in the registry record. These include missing-data handling, the analysis population, the primary endpoint analysis method, multiplicity procedures, and the approach to qualitative analysis. The primary outcome is self-reported, and the record does not say whether sign-in entries were independently verified. The safety entry gives event counts but does not describe event ascertainment or monitoring. These reporting gaps limit interpretation of both the intended measures and the recorded safety figures.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: GameSquad for Adults With Down Syndrome — NCT05473247.
• Registry record last updated 2024-11-25; status last verified 2024-11.
• Results first posted 2024-11-25.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT05473247 is a completed, single-group pilot feasibility study titled GameSquad for Adults With Down Syndrome. The sponsor is University of Kansas Medical Center. The record lists an enrollment of 20, a start date of 2023-01-15, and a primary completion date of 2023-06-30. Allocation is NA, masking is none, and the intervention is a behavioral Ring-Fit Adventure Group.

The primary outcome is minutes of gameplay per week over a 12-weeks timeframe, measured using a self-reported sign-in sheet and intended to be summarized as a mean with standard deviation. The registry record does not report the primary outcome estimate or results for the listed secondary outcomes. It lists zero serious adverse events and zero other adverse events in the intervention group, with 20 at risk for each entry. The record does not report analysis details, missing-data handling, or an analysis population.